Nalbuphine Hydrochloride: Uses,Dosage,Side Effects

Generic Name

Nalbuphine Hydrochloride
Therapeutic Group: Analgesic, Anti Inflammatory/Opioid analgesics

Indications:

• Relief of moderate to severe pain associated with myocardial infarction (MI)
• As a supplement of balanced anesthesia
• Pre-operative and post-operative analgesia
• Obstetrical analgesia during labor and delivery

Presentation:
Nalbuphine 1: Each ml injectable solution contains Nalbuphine Hydrochloride INN 10 mg.
Nalbuphine 2: Each 2 ml injectable solution contains Nalbuphine Hydrochloride INN 20 mg.
Nalbuphine DS: Each ml injectable solution contains Nalbuphine Hydrochloride INN 20 mg.

Description:
Nalbuphine Hydrochloride is a synthetic opioid analgesic, which binds with mu, kappa, and delta receptors. Its analgesic potency is equivalent to Morphine on a milligram basis and 10 times more than that of Pentazocine but has lower side effects and less abuse potential than Morphine. The onset of action of Nalbuphine occurs within 2 to 3 minutes after intravenous administration and in less than 15 minutes following intramuscular injection. The plasma half-life of Nalbuphine is 5 hours and the duration of analgesic activity is 3 to 6 hours.

Dosage & Administration:
The usual recommended adult dose is 10 mg for a 70 kg individual, administered subcutaneously, intramuscularly, or intravenously; this dose may be repeated every 3 to 6 hours as necessary. Dosage should be adjusted according to the severity of the pain, the physical status of the patient, and other medications which the patient may be
receiving.

• Moderate to severe pain: by intravenous or intramuscular injection 10-20 mg for 70 kg patient, adjusted as required; child up to 0.3 mg/kg repeated once or twice as necessary.
• Preoperative anesthesia: by intravenous or intramuscular injection 0.1-0.2 mg/kg.
• Obstetrical analgesia during labor & delivery: by intravenous injection 0.3-1 mg/kg over 10-15 minutes with maintenance doses of 0.25-0.5 mg/kg in single intravenous administration as required.
• Intraoperative analgesia: by intravenous injection 0.25-0.5 mg/kg at 30 minutes intervals.
• Myocardial infarction: By slow intravenous injection 10-20 mg, repeated after 30 minutes if necessary. A larger dose is required when used as a supplement of anesthesia than that required for analgesia.
• Children from 18 months to 15 years old: usually 0.2 mg/ kg body-weight, given preferably by intravenous or intramuscular injection. Maintenance doses may be given at intervals of 4 to 6 hours or the dose must be determined by the physician.

Side Effects:
Generally, Nalbuphine is well tolerated. However few side-effects like sedation, sweating, nausea, vomiting, dizziness, vertigo, dry mouth, headache, respiratory depression, dyspnea, and asthma may be seen.

Precautions:
Caution should be taken in the following conditions: impaired respiration, impaired renal or hepatic function, biliary tract surgery, myocardial infarction, and hypotension.

Use in Pregnancy & Lactation:
Nalbuphine is pregnancy category B. The placental transfer of Nalbuphine is high and rapid. There are no adequate and well-controlled studies on pregnant women. This drug should be used during pregnancy only if clearly needed.

Less than 1% of the administered dose is excreted in milk. However, caution should be exercised when Nalbuphine is administered to a nursing mother.

Overdose:
The immediate intravenous administration of an opiate antagonist such as Naloxone or Nalmefene is a specific antidote. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be used as indicated. Sleepiness and mild dysphoria may occur due to overdose.

Storage:
Keep it in a cool and dry place, protected from light and moisture.